Download Treating Psoriasis - Society of Nurses in Advanced Practice

Treating
Psoriasis:
A Guide to
Understanding
Biologics
Marlee R. Steele DNP, RN, FNP-BC
Disclosures
– I have no financial disclosures related to this
lecture
– Brand names as well as generic names are
provided in the context of this talk for clarity
Learning Objectives
– The participant will be able to identify the different classes of
biologics
– The participant will be able to explain the mechanism of action of
biologics
– The participant will be able to recommend appropriate monitoring
parameters for patients being treated with a biologic
– The participant will be able to identify proper administration of
biologics
– The participant will be able to identify potential side effects of
specific biologics
Psoriasis: Brief Overview
– Chronic noninfectious inflammatory disease of the skin
– Pathologic Process not fully understood
– Develops as secondary response triggered by T Lymphocytes
– T-Cell activation leads to cytokine cascade leading to
inflammation and proliferation of keratinocytes
– Resulting in newly formed cells to move rapidly to the surface
– This occurs every 3-4 days vs normal 26-28 days
– Causing patches to appear
Types of Psoriasis
Biologic Medications
– TNF-Alpha (TNF-α) Inhibitors
– Interleukin-12/23 (IL-12/IL-23) Blockade Agents
– Interleukin-17A
TNF-Alpha (TNF-α)
Inhibitors
– TNF-α
– Cytokine that promotes an inflammatory response
– At high levels can trigger inflammatory response that
leads to excessive keratinocyte proliferation
– Patients with psoriasis have higher levels of TNF-α
– TNF inhibitors bind TNF-α to neutralize its proinflammatory effects in psoriasis
Adalimumab (Humira)
– Fully human anti-TNF-α monoclonal antibody that binds
to and blocks the activation of TNF-α
– Approved for treatment of Moderate-to-Severe Psoriasis
as well as Moderate-to-Severe Psoriatic Arthritis, Adult
and Juvenile Rheumatoid Arthritis, Ankylosing
Spondylitis, Crohn’s Disease, and Hidradenitis
Suppurativa
(HumiraPro, 2017)
Adalimumab (Humira)
– Administration
– Subcutaneous injection
– Prefilled syringe/pen
– Dosage and Frequency
– 80mg day 1
– 40mg day 8
– 40mg day 22
– Continue 40mg every other week
Adalimumab (Humira)
– Monitoring
– Baseline LFT, CBC, Hepatitis Profile, PPD
– After initiation periodic CBC and LFT
– Annual PPD
– Half-Life
– 10-20 days
Adalimumab (Humira)
– Drug Interactions
– Methotrexate
– Biological Products
– Anakinra (Kineret)
– Abatacept (Orencia)
– Rituximab (Rituxan)
– Live Vaccines
– CYP450 Substrates
Adalimumab (Humira)
– Safety Considerations
– Administered to adults 18 years of
age and older
– Pregnancy Category B
– Consideration into stopping
medication during pregnancy
– Increased risk for developing serious
infections
– Patients >65 yrs. of age at greater
risk of developing infection
– Live vaccines should not be
administered
– Safety Considerations Cont.
– Treat latent TB before use
– Considerations for surgery
– Adults should be up to date with
immunizations
– History of malignancy
– Signs or symptoms of infectionpatient should be instructed to
discontinue medication
Adalimumab (Humira)
– Adverse Effects
– Adverse Effects Cont.
– Injections site pain, erythema,
pruritus
– Abdominal pain
– Upper respiratory tract infection
– Hyperlipidemia
– Headache
– Back pain
– Rash
– Hypercholesterolemia
– Sinusitis
– Hematuria
– Increased Creatinine
Phosphokinase
– Hypertension
– Nausea
– UTI
– Flulike symptoms
– Increased alkaline phosphatase
Adalimimab (Humira)
– Black Box Warnings:
– Serious Infection Risk
–
Not to be used with Active TB
–
May cause reactivation of latent TB
–
Treat latent TB infection before use
–
Invasive fungal infections may develop
–
Avoid use in patients with Hepatitis B infection
–
Bacterial infections such as Legionella, Listeria
– Malignancy
–
Lymphoma (Hepatosplenic T-Cell Lymphoma)
–
Leukemia when being used for RA
Etanercept (Enbrel)
– Fully human fusion protein consisting of a soluble TNF
receptor. Binds to both soluble and membrane bound
TNF-α, lowering the amount of available TNF-α,
decreasing the pro-inflammatory effects of TNF-α
– Approved to treat moderate-to-severe psoriasis,
moderate-to-severe psoriatic arthritis, juvenile idiopathic
arthritis, ankylosing spondylitis,
jpet.aspetjournals.org
Etanercept (Enbrel)
– Administration
– Subcutaneous injection
– Prefilled syringe/auto injector
– Adult:
– Initial: >18 years of age 50mg SC twice weekly for 3 months
– Maintenance: 50mg SC once weekly
– Pediatric:
– Initial: >4 years (<63kg)0.8mg/kg SC weekly not to exceed 50mg weekly
– Initial: >4 years (>63kg): 50mg SC weekly
– Dosage and Frequency
– 50mg SC once weekly
Etanercept (Enbrel)
– Monitoring
– Baseline LFT, CBC, Hepatitis Profile, PPD
– After initiation periodic CBC and LFT
– Annual PPD
– Onset
– 1-2 weeks
– Half-Life
– <5 days
Etanercept (Enbrel)
– Drug Interactions
– Orencia
– Kineret
– Cyclophosphamide
– Anti-diabetic medications
– Live Vaccines
Etanercept (Enbrel)
– Safety Considerations
– Pregnancy Category B
–
Consideration to stopping medication
– Increased risk for developing
serious infections
– Patients >65 yrs. of age at
greater risk of developing
infection
– Live vaccines should not be
administered
– Treat latent TB before use
– History of Hepatitis B
– Safety Considerations Cont.
– Heart failure
– Diabetes
– Allergy to rubber or latex
– Children and adults should be up
to date with immunizations
before starting drug
– History of malignancy
– Signs or symptoms of infectionpatient should be instructed to
discontinue medication
Etanercept (Enbrel)
– Adverse Effects
– Adverse Effects Cont.
– Upper respiratory tract
infection
– Dizziness
– Non-upper respiratory
tract infection
– Abdominal pain
– Headache
– Rhinitis
– Nausea
– Pharyngitis
– Vomiting
– Hematologic disorders
Etanercept (Enbrel)
– Black Box Warnings
– Serious Infection Risk
– Not to be used with Active TB
– May cause reactivation of latent TB
– Treat latent TB infection before use
– Invasive fungal infections may develop
– Avoid use in patients with Hepatitis B infection
– Bacterial infections such as Legionella, Listeria
– Malignancy
– Lymphoma
– Leukemia in patient’s with RA
Infliximab (Remicade)
– Part mouse, part human monoclonal antibody that binds
to soluble and membrane bound TNF-α molecules,
inhibiting the pro-inflammatory action of TNF-α
– Approved for treating severe psoriasis, moderate-tosevere psoriatic arthritis, adult rheumatoid arthritis,
ankylosing spondylitis, ulcerative colitis, and Crohn’s
disease
jpet.aspetjournals.org
Infliximab (Remicade)
– Administration
– IV infusion over 2 hours
– Dosage and Frequency
– 5mg/kg IV at 0,2, and 6 weeks then every 8 weeks
Infliximab (Remicade)
– Monitoring
– Baseline LFT, CBC, Hepatitis Profile, PPD
– After initiation periodic CBC and LFT
– Annual PPD
– Onset
– Rapid onset
– Half-Life
– 7-12 days
Infliximab (Remicade)
– Drug Interactions
– Live vaccines
– Biologics
– Kineret
– Orencia
– Actemra
– Methotrexate
– Immunosuppressant's
– CYP450
Infliximab (Remicade)
– Safety Considerations
– Pregnancy Category B
–
Consideration to stopping medication
– Increased risk for developing
serious infections
– Patients >65 yrs. of age at
greater risk of developing
infection
– Live vaccines should not be
administered
– Treat latent TB before use
– Safety Considerations Cont.
– History of Hepatitis B
– History of malignancy
– COPD
– Immunizations should be current
before therapy
– Signs or symptoms of infectionpatient should be instructed to
discontinue medication
Infliximab (Remicade)
– Adverse Effects
– Adverse Effects Cont.
– Development of anti-drug
neutralizing antibodies
– Infusion reaction
– Infection
– Diarrhea
– Upper respiratory tract
infection
– Hepatoxicity
– Abdominal pain
– Nausea
– Headache
– Congestive heart failure
Infliximab (Remicade)
– Black Box Warnings
– Serious Infection Risk
– Not to be used with Active TB
– May cause reactivation of latent TB
– Treat latent TB infection before use
– Invasive fungal infections may develop
– Avoid use in patients with Hepatitis B infection
– Bacterial infections such as Legionella, Listeria
– Malignancy
– Lymphoma (Hepatosplenic T-Cell Lymphoma)
TNF-α Inhibitor’s
Overview
– All TNF Inhibitors carry potential for increased risk for infection with
upper respiratory tract infections being the most common
– Serious infections are uncommon, with patients with underlying
predisposing medical conditions being more at risk
– In the event of an infection requiring an antibiotic the TNF Inhibitor
should be withheld, and more serious infections or opportunistic
infections the TNF Inhibitor should be discontinued
– TNF Inhibitors should be avoided if possible in patient’s with chronic,
serious, or recurring infections
– Reactivation of TB has been associated with TNF Inhibitors
Interleukin 12/23 Blockade
Agents
– IL-12 promotes T-cell differentiation into Th1 cells and
production of IFN-ϒ
– IL-23 induces differentiation of the TH17 T-cell that leads
to inflammation and autoimmunity
– IL-12 and IL-23 contain a p40 subunit that is overexpressed in psoriasis patients causing elevated levels of
IL-12/23
www.nature.com
Ustekinumab (Stelara)
– Monoclonal human antibody that targets IL-12/IL-23
chemical messengers
– Approved to treat moderate-to-severe plaque psoriasis,
psoriatic arthritis, and crohn’s disease in patients 18
years of age and older
Ustekinumab (Stelara)
– Administration
– Subcutaneous Injection (pre-filled syringes)
– IV Infusion
– Dosage and Frequency
– ≤100kg: 45mg SC initially, then 4 weeks later 45mg SC, and then
every 12weeks 45mg SC
– >100kg: 90mg SC initially, then 4 weeks later give 90mg SC, and
then every 12 weeks 90mg SC
Ustekinumab (Stelara)
– Monitoring
– Baseline LFT, CBC, Hepatitis Profile, PPD
– After initiation periodic CBC and LFT
– Annual PPD
– Half-Life
– 10-126 days
Ustekinumab (Stelara)
– Drug Interactions
– Live Vaccines
– CYP450 Substrates
– Concomitant Therapies
– Allergen Immunotherapy
Ustekinumab (Stelara)
– Safety Considerations
– Pregnancy Category B
– Pregnancy should be avoided while on medication
– Increased risk for developing serious infections
– Patients >65 yrs. of age at greater risk of developing infection
– Live vaccines should not be administered
– Treat latent TB before use
– History of malignancy
– Immunizations should be current before therapy
– Signs or symptoms of infection- patient should be instructed to discontinue
medication
Ustekinumab (Stelara)
– Adverse Effects
– Adverse Effects Cont.
– Upper respiratory infection
– Headache
– Nasopharyngitis
– Injection site erythema
– Back pain
– Myalgia
– Cellulitis
– Nasal Congestion
– Depression
– Urticaria
– Diarrhea
– Rash
– Fatigue
Ustekinumab (Stelara)
– Warnings
– May increase risk of infections and/or reactivation of latent
infections
– Increased risk of malignancy
– Non-melanoma skin cancers
– May decrease the protective effect of allergen immunotherapy
– One reported case of Reversible Posterior Leukoencephalopathy
Syndrome
– Avoid pregnancy
Interleukin 12/23 Blockade
Agents Overview
– Serious infections may occur from mycobacteria,
salmonella, and BCG vaccinations in patients genetically
deficient in IL-12/IL-23
– Evaluate patients for TB
– May increase the risk of malignancy
– Hypersensitivity reactions
– Reversible Posterior Leukoencephalopathy Syndrome
(RPLS)
Interleukin-17A (IL-17A)
– Monoclonal antibodies that that target and block the
actions of IL-17A
– Used in the treatment of moderate-to-severe plaque
psoriasis, psoriatic arthritis, ankylosing spondylitis
Secukinumab (Cosentyx)
– Administration
– 150mg prefilled syringe or sensoready pen
– Subcutaneous Injections
– Adults >18 years of age
– Dosage/Frequency
– 300mg SC at weeks 0,1,2,3, and 4
– Monthly maintenance beginning at week 8, 300mg SC once
monthly
www.cosentyx.com
Secukinumab (Cosentyx)
– Monitoring
– Baseline LFT, CBC, Hepatitis Profile, PPD
– After initiation periodic CBC and LFT
– Annual PPD
– Half-Life
– 22-31 days
Secukinumab (Cosentyx)
– Safety Considerations
– Pregnancy Category B
– While Category B it is recommended to stop medication
– Live vaccines should not be administered
– Caution in considering use in patients with chronic infection or history
of recurrent infection
– Immunizations should be current before therapy
– Treat latent TB before use
– May exacerbate Crohn’s Disease
Secukinumab (Cosentyx)
– Adverse Effects
– Adverse Effects Cont.
– Infections
– Oral Herpes
– Nasopharyngitis
– Pharyngitis
– Diarrhea
– Urticaria
– URT Infection
– Rhinorrhea
– Rhinitis
– Anaphylaxis
Secukinumab (Cosentyx)
– Drug Interactions
– CYP450 substrates
– Live Vaccines
– Non-Live Vaccines
Ixekizumab (Taltz)
– Administration
– Subcutaneous injection
– Auto injector or Prefilled Syringe
– Adults >18 years of age
– Dosage/Frequency
– Week 0- 160mg SC
– Week 2,4,6,8,10,& 12 80mg SC
– Then 80mg SC every 4 weeks
Ixekizumab (Taltz)
Ixekizumab (Taltz)
– Monitoring
– Baseline LFT, CBC, Hepatitis Profile, PPD
– After initiation periodic CBC and LFT
– Annual PPD
– Half-Life
– 13 days
Ixekizumab (Taltz)
– Drug Interactions
– Live Vaccines
– CYP450 Substrates
Ixekizumab (Taltz)
– Safety Considerations
– Pregnancy Category B
– While Category B it is recommended to stop medication
– Live vaccines should not be administered
– Caution in considering use in patients with chronic infection or history
of recurrent infection
– Immunizations should be current before therapy
– Treat latent TB before use
– May exacerbate Crohn’s Disease
Ixekizumab (Taltz)
– Adverse Effects
– Injection site reactions
– Upper Respiratory Tract Infections
– Serious Infections
– Nausea
– Tinea Infections
– Hypersensitivity reactions
Ixekizumab (Taltz)
– Warnings
– Serious hypersensitivity reactions such as angioedema and
urticarial
– Discontinue use of Taltz while patient is being treated for
infection
Interleukin 17-A (IL-17A)
Overview
– In the event of an infection requiring an antibiotic the IL-17A
should be withheld, and more serious infections or opportunistic
infections the IL-17A should be discontinued
– May cause inflammatory bowel disease exacerbations, patient’s
who have inflammatory bowel disease should be monitored
closely
– Evaluate patient for TB prior to initiating therapy
Guide to Prescribing
Biologics
– Complete history and physical examination
– Identifying any potential contraindications to therapy
– Past treatment
– Topical therapy indicated for patient’s with plaque type psoriasis with
less than 5% BSA
– Systemic therapy- including biologics and phototherapy appropriate
for patients with >5% BSA
– Patient’s with <5% BSA are candidates for systemic therapy if they
have failed topical therapy, or difficult-to-treat areas
– Lab work
The End
References
– Gottlieb, A., Kardos, M., & Yee, M. (2009). Current biologic treatments for
psoriasis. Dermatology Nursing, 21,259-272.
– Herrier, R. (2011). Advances in the treatment of moderate-to-severe plague
psoriasis. American Society of Health-System Pharmacists, 68, 795-806.
doi:10.2146/ajhp100227
– Krueger, J. (2002). The immunologic basis for the treatment of psoriasis with
new biologic agents. American Academy of Dermatology, 1-23.
doi:10.1067/mjd.2002.120568
– Loss L., & Kalb, R. (2009). Psoriasis therapy. Disease Management, 15-20.
References
– Menter, A., Gottlieb, A., Feldman, S., Voorhees, A., & Leonardi, C. et. al. (2008).
Guidelines of care for the management of psoriasis and psoriatic arthritis.
American Academy of Dermatology, 826-850. doi:10.1016/j.aad.2008.02.039
– Phung, O., White, M., & Coleman, C. (2009). Ustekinumab: A human
monoclonal antibody for the treatment of plaque psoriasis, Formulary Journal,
44, 72-76.
– Roman, M., Madkan, V., & Chiu, M. (2015). Profile of secukinumab in the
treatment of psoriasis: current perspectives. Therapeutics and Clinical Risk
Management, 11, 1767-1777. doi: 10.2147/TCRM.S79053
– Thomas, V., Yang, C., & Kvedar, J. (2005). Biologics in psoriasis: A quick reference
guide. American Academy of Dermatology, 53, 346-351.
doi:10.1016/j.jaad.2005.04.011